Kornimate/medical-research-clean huggingface dataset:
peri-operative cefazolin prophylaxis at time of cesarean delivery in the obese gravida

Conditions: Obesity; Pregnancy

Summary: obesity has become an increasingly prevalent public health problem in the united states, reaching epidemic proportions. according to 2009 cdc epidemiologic data on obesity in the united states, 35.7% of the united states population is considered overweight or obese. currently, on the review of the literature, over 20% of pregnancies in this country are complicated by maternal obesity. obesity has been well demonstrated to be correlated with numerous adverse pregnancy outcomes such hypertensive disorders of pregnancy, gestational diabetes, and increased rates of operative delivery. moreover, obesity, irrespective of pregnancy, has been demonstrated to be an independent risk factor for the development of postoperative surgical site infections. development of such infections can have both consequential long-term medical sequelae for patients and economic impacts on the health care system at large. cefazolin, a first generation hydrophilic cephalosporin whose clearance is exclusively mediated via the kidneys unchanged, is used as pre-operative antibiotic prophylaxis for cesarean deliveries. the current accepted standard of care is to administer 2 grams of cefazolin within 60 minutes of skin incision. studies of drug concentrations of cephalosporins for pre-operative antibiotic prophylaxis in obese bariatric patients have shown that therapeutic concentrations may not be achieved in both tissue and plasma. limited data exist in pregnancy. therefore, it is the goal of this study to investigate whether obese patients presenting for cesarean delivery require an increased dosing amount of pre-operative antibiotic prophylaxis. this study will randomized women with a pre-pregnancy body mass index of 30 kg/m2 or more who are presenting for their scheduled cesarean delivery to receive either 2 grams or 3 grams of cefazolin for pre-operative antibiotic prophylaxis. by drawing blood at specific time points in the peri-operative period and extracting adipose tissue samples during cesarean delivery, this study will investigate the pharmacokinetics of cefazolin in both the plasma and tissues of the obese gravida.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) greater than 30kg/m2 * those women having scheduled primary or repeat cesarean delivery exclusion criteria: * type 1 and type 2 insulin dependent diabetes mellitus * autoimmune disease, including systemic lupus erythematosus * history of chronic renal disease * those using chronic corticosteroids * those with a history of a previous wound breakdown * those who have an allergy to cephalosporins whose reaction includes anaphylaxis, urticaria or other systemic consequences * those who are unable to receive their antibiotics in a timely fashion

Keywords: cesarean delivery
comparison of eplivanserin and lormetazepam in the treatment of insomnia characterized by sleep maintenance difficulties

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the primary objective is to compare the potential for next-day residual effects of eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties. the secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.


Eligibility criteria:
inclusion criteria: * primary insomnia according to diagnostic and statistical manual of mental disorders (dsm-iv-tr) criteria * at least 1 hour of wakefulness for at least 3 nights per week during the month preceding inclusion * disturbances of sleep maintenance criteria based on the patient's sleep questionnaire during the run-in period exclusion criteria: * pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control * night shift workers and individuals who nap 3 or more times per week * consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day * insomnia secondary to a general medical condition the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: primary insomnia sleep maintenance difficulties
tramadol infiltration for tonsillectomy

Conditions: Postoperative Pain

Summary: the purpose of this study is to evaluate the analgesic effect and il-6 after tramadol infiltration or intravenous for tonsillectomy.

the study will be prospective, double-blind, randomized study of 40 children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy under general anesthesia. patients will be allocated into two groups. group 1 patients will receive tramadol 2 mg / kg intravenously and saline 0.9% infiltration in tonsils; group 2, will receive tramadol 2 mg / kg infiltration and intravenous saline. there will be evaluated: postoperative pain intensity by facial scale, supplementary analgesics and interleukin-6. for statistical analysis of the results will be used parametric and nonparametric tests, taking into account the nature of the variables. the level of statistical significance will be set at \< 0.05.

Eligibility criteria:
inclusion criteria: * children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy exclusion criteria: * coagulopathy, * cancer, * hepatic or renal alteration

Keywords: tramadol infiltration analgesic effect serum il-6
milnacipran in autism and the functional locus coeruleus and noradrenergic model of autism

Conditions: Autism Spectrum Disorder; Asperger Syndrome; Aspergers Syndrome

Summary: autism spectrum disorders (asd) include autistic disorder, asperger's syndrome and pervasive developmental disorder not otherwise specified (pdd-nos). these are developmental disorders beginning prior to three years of age. recent centers for disease control (cdc) estimates suggest that asd affects up to 1 in 100 individuals and up to 1 in 50 boys. there are very substantial costs associated with caring for patients with asd, and asd has the highest caregiver burden scores of any condition. there are three core symptom domains of asd, including social deficits, repetitive behaviors and language deficits. patients can also have associated symptoms of attentional deficits, disruptive behaviors and intellectual disability. there is currently no food and drug administration (fda) approved treatment for the core symptoms of autism, but risperidone and aripiprazole have fda approval for disruptive behaviors associated with autism. this is a 12 week randomized double blind placebo controlled trial of milnacipran in adults with asd or aspergers syndrome. milnacipran is said to play a role in the activation and normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a role in behavior adaptations and performance.


Eligibility criteria:
inclusion criteria: * male and female patients * aged 18-50 years * diagnosis of autism spectrum disorder * intelligence quotient greater than 70 exclusion criteria: * pregnant subjects * patients deemed by comprehensive psychiatric interview to have a significant risk of suicide

Keywords: asd autism autism spectrum disorder asperger syndrome asperger pdd pdd-nos
justification of incidental appendectomy with respect to pathohistological findings

Conditions: Appendix Tumor

Summary: this study seeks to justify performing an incidental appendectomy according to the following hypotheses: 1. the frequency of neoplasms in pathohistological (phd) findings of incidental appendectomy (ia) is significantly higher than in phd findings in appendectomies for acute appendcitis (aa) 2. the number needed to treat (nnt) for appendiceal tumors in the elderly is less than 500. 3. the rate of complicated aa in the elderly population is significantly higher than in the younger age group 4. nnt ia for complicated appendicitis in the elderly is less than 300. 5. nnt ia for potential death due to aa in the elderly is less than 500.

a retrospective cross-sectional study will be done. the archive of all phd findings will be searched, and then the relevant medical histories at the clinic of surgery, university hospital center split in the period from 01.01.2017. to 31.12.2021. the data collection will be done in the period from 01.02.2022. to 31.03.2022. the data collection (extraction) will be done by the main researcher (graduate, ante tavra) with at least two other colleagues from the department of abdominal-coloproctological surgery, university hospital center split (damir quien, md and dora bjelanović, md). data will be collected directly from medical history and entered into an overview table. the identity of the respondents will remain secret, and the respondents will be marked exclusively with an identification number. this type of research does not require the informed consent of the patient, and all data collected will be kept in accordance with the provisions of annex 2 of the application to institutional advisory board of uhc split (approval pending).

Eligibility criteria:
inclusion criteria: adult patients operated for colon tumors who have data on age, sex, data on a previously diagnosed colon tumor, data on incidental appendectomy, and a phd finding for a removed appendix. adult patients who have been diagnosed with acute appendicitis and have data on age, sex, data on the diagnosis of acute appendicitis and accompanying phd findings, newly performed appendectomies. exclusion criteria: we will exclude from the analysis patients who had previous appendectomy, appendectomy has not been performed or we do not have an accompanying phd finding of the appendix, and patients younger than 18 years.
a study examining maintenance bevacizumab (avastin®) monotherapy in participants with advanced lung adenocarcinoma

Conditions: Lung Adenocarcinoma

Summary: this prospective, open-label, single arm, non-interventional study will investigate the effectiveness of bevacizumab monotherapy in participants with lung adenocarcinoma who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab.


Eligibility criteria:
inclusion criteria: * participant who previously received 4 to 6 cycles of induction platinum doublet plus bevacizumab * participant who received only 1 cycle of bevacizumab maintenance treatment * meet summary of product characteristics guidelines exclusion criteria: * participant who received the first cycle of maintenance bevacizumab more than 4 weeks after the postinduction tumor assessment * pregnant or breast-feeding
efficacy and safety of sofosbuvir/velpatasvir fixed dose combination for 12 weeks in participants with chronic hcv

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (sof)/velpatasvir (vel; gs-5816) fixed-dose combination (fdc) for 12 weeks in participants with chronic hepatitis c virus (hcv) infection.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * hcv rna ≥ 10\^4 iu/ml at screening * chronic hcv infection (≥ 6 months) documented by prior medical history or liver biopsy * any hcv genotype (1, 2, 3, 4, 5, 6 or indeterminate) * hcv treatment-naive or treatment-experienced * liver imaging within 6 months of day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (hcc) key exclusion criteria: * current or prior history of clinically-significant illness (other than hcv), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug * pregnant or nursing female or male with pregnant female partner * chronic liver disease of a non hcv etiology * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) note: other protocol defined inclusion/exclusion criteria may apply.
dental probe (dental practice survey of office blood pressure measurement)

Conditions: Focus of Study is on Dentist's Attitudes Toward BP Measures

Summary: 20% of canadians are hypertensive with approximately 200,000 new cases each year. early detection of hypertension affects outcomes, reducing the risk for heart attack, stroke, kidney disease, and dementia. screening strategies are required to identify the more than one third of canadians with unrolled high blood pressure, in particular, younger men unaware of their condition, women over sixty years old, and underserved groups. a collaborative practice model linking dentists to other healthcare providers in a reporting network is a promising model for hypertension detection and management. there are 20,129 licensed dentists in canada who graduate with the ability to measure blood pressure, and 74% of the population visits a dentist each year. this represents an opportunity, but information is required on dental attitudes toward screening for hypertension before attempting to initiate a screening model. to engage dentists in hypertension detection requires an understanding of the practice environment and the factors that shape their beliefs, attitudes and behaviours regarding routine hypertension screening in their practices.


Eligibility criteria:
inclusion criteria: * dentists in practice exclusion criteria: * unwilling to participate in study

Keywords: hypertension dentistry blood pressure measurement screening qualitative research
qol and adherence to one-pill once-a-day haart

Conditions: HIV Infection; HIV Infections

Summary: primary objective of the study is: to verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients.


Eligibility criteria:
inclusion criteria: * age \> 18 years * informed consent signed * effective ongoing treatment (hiv-rna \< 50 copies/ml) for at least three months * being on a stable haart regimen based either on two possible drug associations: * 3tc/ftc + tdf + efv * ftc/tdf (fixed dose combination) + efv * no previous documented virologic failure exclusion criteria: * childbearing or breastfeeding. women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours * any ongoing grade 4 laboratory abnormality

Keywords: adherence qol virologic efficacy immunologic efficacy patients' preference once-daily haart treatment experienced
marker guided breathhold radiotherapy in nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: proof of concept study evaluating safety and performance of a gel marker (bioxmark) used for image guidance in deep inspiration breathhold radiotherapy (dibh igrt) in patients with locally advanced non-small cell lung cancer (nsclc)


Eligibility criteria:
inclusion criteria * age \> 18 years old * histologically confirmed non-small cell lung cancer (nsclc) * stage t1-4n1-3m0 * performance status ≤ 2 * inoperable * fev1 ≥ 1 l * ability to hold deep inspiration breathhold for \> 15 seconds * accepting treatment at rigshospitalet * eligible for concomitant chemo-radiotherapy * if a woman is of childbearing potential, a negative pregnancy test must be documented * ability to understand the given information * signed written consent for inclusion into the study exclusion criteria * prior thoracic radiotherapy * allergy to iodine or iodine based contrast * in the opinion of the investigator, the patient will not be able to follow the study procedures or is considered not eligible for other reasons
prostate hypoxia faza

Conditions: Prostate Cancer

Summary: the purpose of this study is to look for low levels of oxygen (hypoxia) in prostate cancer using a special x-ray test called a positron emission tomography (pet)scan. hypoxia may have an effect on how prostate cancer grows and responds to treatments like radiotherapy and chemotherapy. the use of pet scans to measure hypoxia may be better and simpler than the methods used previously.


Eligibility criteria:
inclusion criteria: * age =\> 18 years * histologic diagnosis of adenocarcinoma of the prostate * bulky intermediate risk, high risk or metastatic prostate cancer bulky intermediate risk: ct1-2 with \>50% of diagnostic biopsy cores containing cancer and gleason 6 or 7 and prostate specific antigen (psa) \>10 and ≤20 or high risk: ct1-2 with gleason score ≥8; or ct1-2 with psa \>20; or ct3 or n+ and/or m1 disease or newly diagnosed hormone-refractory prostate cancer - intention to treat using radiotherapy +/- concurrent and adjuvant hormonal therapy * intention to treat with radiotherapy, hormonal therapy, other systemic treatment for prostate cancer, or a combination of these according to the princess margaret genitourinary site policies. * previous or concurrent anti-cancer therapy for the pet faza target lesion allowed * ability to provide written informed consent to participate in the study exclusion criteria: * inability to lie supine for more than 60 minutes * patients taking the drug disulfiram (antabuse) * contraindications for mri: only applicable in cases where the pet faza target lesion is identified as the prostate gland. patients with target lesions at other anatomic sites will not undergo mr imaging. * patients weighing \> 136 kg

Keywords: procedure/surgery: 18f-fluoroazomycin arabinoside (18f-faza)
natural history study protocol in pmm2-cdg (cdg-ia)

Conditions: Phosphomannomutase 2 Deficiency

Summary: clinical and basic investigations into phosphomannomutase deficiency (pmm2-cdg) this is a natural history (observational) protocol designed to collect clinical and biological information in patients with pmm2-cdg (cdg-ia).

subjects enrolled in this natural history study will be thoroughly examined for signs and symptoms of pmm2-cdg. medical history, physical examination, laboratory testing and imaging studies will be performed during a single consultation. follow-up will occur every 3- 6 months at a minimum, depending on the standard of care at the investigator's institution as well as the clinical status of the individual patient. all medical procedures are routine. no new therapy is offered as part of this study, and no change in the patients routine therapy is dictated by this protocol. the international co-operative ataxia rating scale (icars) is to be performed every 3 months as an optional assessment. no randomization will be performed.

Eligibility criteria:
inclusion criteria: * informed consent/assent by the patient and/or their legally authorized representative * confirmed diagnosis of pmm2-cdg, based on enzymatic or molecular tests * willing and able to adhere to study requirements described in the protocol and consent/assent documents exclusion criteria: * known or suspected differential diagnosis of any other known cdg (not pmm2-cdg) * currently using investigational drug * blood loss of ≥ 250 ml or donated blood within 56 days, or donated plasma within 7 days before study screening

Keywords: pmm2-cdg cdg-ia
a prospective, us-based study assessing mogamulizumab-associated rash in patients diagnosed with mycosis fungoides or sezary syndrome and treated with standard of care mogamulizumab

Conditions: Recurrent Mycosis Fungoides; Recurrent Sezary Syndrome; Refractory Mycosis Fungoides; Refractory Sezary Syndrome; Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8

Summary: this study is being done to assess mogamulizumab-associated rash in patients diagnosed with mycosis fungoides or sezary syndrome and treated with standard of care mogamulizumab. one of the most common side effects of mogamulizumab is a rash, currently named mogamulizumab-associated rash (mar) which can look like mf or ss. however, mogamulizumab-associated rash (mar) does not indicate failure of mogamulizumab, and may be a sign that the drug is working. if not properly evaluated, mogamulizumab-associated rash (mar) could be misinterpreted as worsening of mycosis fungoides/sezary syndrome, which could lead doctors to recommend stopping mogamulizumab treatment early. the information learned by doing this research study may help tell the difference between mogamulizumab-associated rash (mar) (sometimes also called "drug eruption") and worsening of the disease. it may also help to uncover information about the cause of mogamulizumab-associated rash (mar).

primary objective: i. to assess the incidence of mogamulizumab-associated rash (mar) and its association with overall response in patients with cutaneous t-cell lymphoma (ctcl); mycosis fungoides \[mf\] and sezary syndrome \[ss\] subtypes) treated with mogamulizumab. outline: this is an observational study. patients complete questionnaires, have photographs of their skin taken, and undergo blood sample collection and skin biopsies on study. patients' medical records are also reviewed.

Eligibility criteria:
inclusion criteria: * \* adult patients (\>= 18 years of age) diagnosed with relapsed/refractory mycosis fungoides (mf) stage ib, iia, iib, iii and iv or sezary syndrome(ss), and selected by their treating physician to receive single agent mogamulizumab (newly initiated) * signed informed consent * willing to undergo baseline biopsy and during treatment to evaluate for mogamulizumab-associated rash (mar) if clinically indicated * willing to provide blood sample at baseline, and if applicable, at onset of mogamulizumab-associated rash (mar) exclusion criteria: * \* other concomitant systemic and skin directed cutaneous t-cell lymphoma (ctcl) regimens except for topical steroids * prior treatment with mogamulizumab
analysis of expression of specific markers in hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma is an aggressive disease with limited therapeutic options. therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. as a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out. this will be done retrospectively using available hepatocellular carcinoma tissue samples.


Eligibility criteria:
inclusion criteria: * the patient had pathologically proven hepatocellular carcinoma * all the data required are available from patient's records * a sufficient amount of rna is available for all three tissue samples exclusion criteria: n/a

Keywords: markers expression analysis